BIOSTATISTICS AND BIOINFORMATICS SHARED RESOURCE Project Summary The primary goal of the Biostatistics and Bioinformatics Shared Resource (BBSR) is to facilitate the peer- reviewed research of Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) members. The BBSR collaborates with members from all four scientific Programs throughout all phases of cancer-related research projects. Major responsibilities are assumed for methodological, statistical, bioinformatics, and computational issues, including study design, sampling, statistical aspects of clinical trial monitoring, interim reviews, and final analysis. The BBSR supports the following five areas: 1) Clinical Protocol Development, including development of appropriate statistical designs, preparing statistical sections, and reviewing the statistical content of all protocols submitted for review at the WFBCCC; 2) Clinical Protocol Monitoring and Analyses, including monitoring patient accrual, providing support for quality assurance efforts, and performing interim (when needed) and final analyses; 3) Statistical Design and Data Analysis in Support of Grant Development and Publications, which includes collaborations with WFBCCC investigators from all Programs to provide guidance and support in all stages of research studies and grants. This aspect of service involves meeting with WFBCCC investigators to discuss the design and analysis plans for potential grants, conducting regular planning sessions with WFBCCC investigators about potential grants, performing statistical analyses of data and providing interpretations of results as parts of presentations, abstracts, and publications; 4) Informatics Services to WFBCCC investigators from all Programs, including genomics data processing, bioinformatics analyses, data annotation and visualization/sharing to support basic, translational and clinical cancer research by leveraging the institutionally-maintained Translational Data Warehouse; and 5) Leadership, Education, and Training, including participation in graduate-level courses, T32 training grants, mentoring teams for K awardees and other young investigators, membership/leadership on committees responsible for scientific and administrative decisions for the WFBCCC, and coordination of a monthly seminar series and short courses on statistical and/or bioinformatics methods for WFBCCC members. The BBSR is co-directed by Ralph D?Agostino, Jr., Ph.D., and Xiaobo Zhou, Ph.D., and is a highly utilized and cost-efficient Resource for the WFBCCC. From November 1, 2014 through October 31, 2015, the BBSR provided over 5,000 hours of support for cancer-related work and assisted 105 investigators (90 WFBCCC Members) from all four WFBCCC Programs while receiving approximately 1.9 FTEs of financial support from the Cancer Center Support Grant (with additional support provided by WFBCCC institutional dollars). In addition, during the reporting year the BBSR provided statistical support to 23 newly-opened investigator initiated protocols, provided support for 20 clinical protocol audits, reviewed over 120 protocols for statistical content, monitored over 200 open protocols, assisted in 39 published manuscripts in 2015 (over 185 total during grant period), assisted on 20+ extramural grant submissions, and collaborated on over 22 currently funded cancer-related grants with combined direct costs for 2014 of approximately $8.1 million.